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Prenatal studies make history

by Dawn Brazell
Public Relations
Becoming part of obstetrical history with its participation in a second national fetal growth study, MUSC will help establish the gold standard for what is normal growth and development of twins.

MUSC initiates its second landmark obstetrical ultrasound study - this time focusing on twins. The photo above is a 4D ultrasound image of Jennifer Montgomery’s twin boys at 25 weeks of gestation.

MUSC is one of five hospitals chosen to be a part of the National Twins Study, which will begin recruiting women this month to be a part of this research sponsored by the Eunice Kennedy Shriver National Institutes of Child Health and Human Development.

Roger Newman, M.D., the study’s principal investigator, said this is the second nationally important study using obstetrical ultrasound that has been undertaken by the Maternal-Fetal Medicine service at 135 Cannon Place, a part of MUSC’s Department of Obstetrics and Gynecology.

“It’s important for us to be part of these studies. The selection of the study sites was to create geographic and ethnic diversity in terms of recruitment. What also makes us a good selection is the quality of the prenatal ultrasound services that we offer. Our research infrastructure in the Department of OB-GYN is very strong and we are able to deliver on what we say we can do.”

The hospital began recruiting to the National Standard for Normal Fetal Growth Study, also sponsored by the National Institutes of Health, in 2009. That study runs through March 2012 and uses ultrasound to redefine what represents normal fetal growth in healthy women pregnant with one child.

Dr. Roger Newman displays the T-shirt that is given to the study’s participants.

Newman said both of these studies are important because they rely on the latest technologies in ultrasound imaging, an important part in assuring normal fetal growth, which is critical to the long-term health and well-being of the child.

The studies will help set a comparative gold standard to determine if fetal growth is normal, restricted or excessive. Most current growth standards are based on fairly small populations, and many of these studies were performed 30 to 40 years ago with ultrasound technologies inferior to what is available today. Another complicating factor is that those studies included women who had risk factors for impaired fetal growth. A true gold standard should be based upon fetal growth in low risk women without medical or obstetrical complications, he said.

The National Twins Study will be recruiting 500 patients from five centers nationwide, 50 from MUSC, while the fetal growth study will be recruiting 2,400 women, about 500 from MUSC. Investigators are collecting data that will allow them to develop customized fetal growth curves that can be adjusted for maternal factors such as age, race, parity, weight and height as well as for fetal gender. These studies will set new standards for what represents normal fetal growth based on individual maternal and fetal variables using ultrasounds instead of the previous standard, which involved measuring the fundal height, he said. The lack of quality, prospective longitudinal studies has left major gaps in the understanding of what should be considered normal versus abnormal growth.

“Each baby will be evaluated against its own individual growth potential—not against some standard set in some other population. When you’re dealing with millions of pregnancies, even small differences become magnified within an entire population. Your baby should not be evaluated using the same growth curve as another woman who is a different size or ethnicity.”

Newman said the new standards will help doctors know better when they should or should not intervene in a pregnancy. The twins study also will answer important questions about differences between single and twin gestations, between identical and fraternal twins and what degree of growth discordance between co-twins is clinically acceptable.

“It’s a reflection of the high quality of prenatal ultrasound offered at MUSC that our Prenatal Wellness Center was chosen for these NIH-funded, national studies,” said Newman. “We’ve developed a nationally- recognized prenatal diagnostic center, which enjoys a great reputation. We see referrals from the lower half of South Carolina.”

In addition to MUSC, these two studies also are being performed at Columbia University in New York City, Northwestern University in Chicago, the University of California at Irvine, and the Women & Infants Hospital in Providence, R.I. All of the participating centers underwent rigorous pre-selection review and credentialing of both the sonographers and investigators. There also is an ongoing quality review of submitted scans.

Newman likes it that South Carolina women and their babies will be helping to set the new standards. He holds up a T-shirt with the study’s slogan— ‘This is one of the 3,000 most important babies in the U.S.’

“It’s a great credit to our center and our university to be a part of this. We’re excited to be participating in this.”

Registered nurse Carolyn G. Williams holds up the onesie that babies in the prenatal studies get to wear.

MUSC prenatal study requirements
Want to be a study participant?
National Standard for Fetal Growth Study Pregnant women eligible for the study must be:
  • in the first trimester (less than 14 weeks) q have a known last menstrual period
  • be a nonsmoker
  • and be free of any other significant medical or obstetrical complications.
National Twins Study
Requirements for the National Twins Study are not quite as rigorous. Smoking and other high-risk conditions are not exclusions. To be eligible, mothers of twins need to be:
  • in the first trimester (less than 14 weeks)
  • and have a known last menstrual period.
Women from minority groups especially are needed. One of the goals of these studies is to recruit equal numbers of Caucasians, African- Americans, Hispanics and Asians so that the results accurately reflect the diversity of the national population.

What to expect?
Once enrolled, women receive:
  • A total of six ultrasound exams during their pregnancy, which include a comprehensive evaluation with 2-D and 3-D images of all fetal and maternal structures.
  • At each ultrasound visit, mothers will be interviewed, measured (including the fundal height), complete a 24-hour dietary recall and, on some visits, asked to provide a small blood sample.
  • After delivery, both and mother and baby will be physically measured as part of the newborn assessment.
There are no costs associated with participation in these studies as funding for all study-related procedures and ultrasounds is being provided by the National Institutes of Health.

Compensation is offered for the time commitment involved. Each participant also will receive a CD, which includes all of the 2-D and 3-D images obtained during ultrasounds. Participants will receive a T-shirt with the National Fetal Growth Study logo recognizing their participation. The mother’s T-shirt states: ‘My baby is one of the 3,000 most important babies in the United States’ and the baby’s onesie states: ‘I am the standard by which all other babies are judged.’

For more information about the National Fetal Growth Study or the National Twins Study, call any of the MUSC prenatal care sites and ask to speak to a research coordinator.
  • Carolyn Williams (792-0349) is available for women receiving prenatal care at Cannon Place, Northwoods or at MUSC Family Medicine.
  • Holly Boggan (876-1434) sees patients at the East Cooper Women’s Center practice.
  • Sarah Cordell (792-6654) sees women at Cannon Place downtown as well as the West Ashley Women’s Health office.

Friday, Jan. 21, 2011

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